APIs contaminated by Tianjin blast turn up in U.S., FDA warns

Damage from a chemical warehouse explosion in Tianjin, China

A massive explosion at a chemical warehouse in Tianjin, China, last summer spread death, destruction and contamination for square kilometers around the port's industrial area. Some of that contamination has now reached the U.S., showing up in active ingredients that were manufactured by a company that sits 30 kilometers from the blast site.

The FDA warned drugmakers and compounders on Tuesday that it had discovered hydrogen cyanide contamination in two shipments of drugs from Tianjin Tianyao Pharmaceuticals, whose plant is about 18 miles from the blast site. Two other shipments from the company were released after tests found them free of hydrogen cyanide, the agency said. It said the shipments appear to have been headed to pharmacy compounders.

The FDA is working with the China Food and Drug Administration (CFDA) on this issue and said contaminated shipments have been stopped. But it reminded drugmakers at every level that they are responsible for ensuring their products are not contaminated with toxic chemicals and that they need to be especially careful of APIs, excipients or finished drugs coming out of the Tianjin area.

The series of blasts during the night in August killed more than 140 people, destroyed thousands of cars awaiting shipping, crumpled shipping containers and collapsed buildings. The FDA said while there is not a lot of info on what was released by the blast, more than 40 different types of chemicals were discovered at the blast site. News reports said that calcium carbide, sodium cyanide, potassium nitrate, ammonium nitrate and sodium nitrate were stored in the warehouse. The explosion's cause has not been officially released, but Reuters has reported that China formally detained a dozen people in relation to the explosions and accused 11 officials and port executives of dereliction of duty or abuse of power.

Among the companies affected is GlaxoSmithKline ($GSK), which had to close a plant in Tianjin that was damaged by the blast. No GSK employees were injured, but spokesman Simon Steel said in an emailed statement at the time that the company was "exploring alternative supply options" as its worked to restore manufacturing at the plant.

Even before the explosion, GSK was having issues at the Chinese facility. The European Medicines Agency banned shipment of its products to Europe after U.K. inspectors turned up problems. They said dating back a decade, GSK has had tablet discoloration in stability samples of over-the-counter heartburn med Zantac that did not meet specs for shelf life. The problems indicated "non-sterile" manufacturing and packaging, the report says.

- read the FDA drug safety warning

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